Tovanor Breezhaler

glycopyrronium bromide

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This is a summary of the European public assessment report (EPAR) for Tovanor Breezhaler. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tovanor Breezhaler.

For practical information about using Tovanor Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.

What is Tovanor Breezhaler and what is it used for?

Tovanor Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Tovanor Breezhaler is used for maintenance (regular) treatment.

Tovanor Breezhaler contains the active substance glycopyrronium bromide.

How is Tovanor Breezhaler used?

Tovanor Breezhaler capsules, which contain a powder for inhalation, are only used with the Tovanor Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

The recommended dose is one capsule once a day at the same time each day. Patients should not use more than one capsule in a day.

Tovanor Breezhaler can only be obtained with a prescription.

How does Tovanor Breezhaler work?

The active substance in Tovanor Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.

What benefits of Tovanor Breezhaler have been shown in studies?

Tovanor Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. In both studies, the main measure of effectiveness was improvement in patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).

After 12 weeks of treatment, Tovanor Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.

What are the risks associated with Tovanor Breezhaler?

The most common side effects with Tovanor Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects and restrictions with Tovanor Breezhaler, see the package leaflet.

Why is Tovanor Breezhaler approved?

The Agency noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. In addition, there were no major safety concerns with Tovanor Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. Therefore, the Agency decided that Tovanor Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Tovanor Breezhaler?

As muscarinic receptor antagonist medicines may have an effect on the heart and blood vessels, the company that markets Tovanor Breezhaler will continue to closely monitor the medicine’s cardiovascular effects and will carry out a further study in patients to identify any potential risks.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tovanor Breezhaler have also been included in the summary of product characteristics and the package leaflet.

Other information about Tovanor Breezhaler

The European Commission granted a marketing authorisation valid throughout the European Union for Tovanor Breezhaler on 28 September 2012.

For more information about treatment with Tovanor Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Tovanor Breezhaler : EPAR - Summary for the public BG = bălgarski 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public ES = español 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public CS = čeština 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public DA = dansk 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public DE = Deutsch 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public ET = eesti keel 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public EL = elliniká 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public EN = English 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public FR = français 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public IT = italiano 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public LV = latviešu valoda 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public LT = lietuvių kalba 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public HU = magyar 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public MT = Malti 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public NL = Nederlands 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public PL = polski 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public PT = português 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public RO = română 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public SK = slovenčina 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public SL = slovenščina 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public FI = suomi 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public SV = svenska 2012-10-17 2017-08-04
Tovanor Breezhaler : EPAR - Summary for the public HR = Hrvatski 2012-10-17 2017-08-04

This EPAR was last updated on 31/08/2017 .

Authorisation details

Product details

Product details for Tovanor Breezhaler
NameTovanor Breezhaler
Agency product numberEMEA/H/C/002690
Active substance

glycopyrronium bromide

International non-proprietary name (INN) or common name

glycopyrronium bromide

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03BB06
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Tovanor Breezhaler
Marketing-authorisation holder

Novartis Europharm Ltd.

Revision9
Date of issue of marketing authorisation valid throughout the European Union28/09/2012

Contact address:

Novartis Europharm Ltd.
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

Product information

16/08/2017  Tovanor Breezhaler -EMEA/H/C/002690 -N/0025

Name Language First published Last updated
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31
Tovanor Breezhaler : EPAR - Product Information HR = Hrvatski 2012-10-17 2017-08-31

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30
Tovanor Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2012-10-17 2015-06-30

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Tovanor Breezhaler : EPAR - Public assessment report HR = Hrvatski 2012-10-17  
CHMP summary of positive opinion for Tovanor Breezhaler HR = Hrvatski 2012-06-22 2012-08-07

Authorised

This medicine is approved for use in the European Union